NCT05998694

Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis

Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis "ТiAra" (T-ara)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Closed Joint-Stock Company NeoCor · Academic / Other
• Sex: All
• Age: 60 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this multicenter prospective cohort study is to evaluate the long-term safety and efficacy of clinical outcomes of aortic valve replacement using the "TiAra" prosthesis with or without concomitant procedures. Main research objectives: 1. To analyze the short and mid-term (up to 3 years) outcome of aortic valve replacement using the "TiAra" prosthesis. 2. To study the hemodynamic characteristics of normally functioning "TiAra" prostheses in the aortic position, as well as the condition of the heart chambers in short and long-term period (up to 10 years) after the implantation. 3. To assess complications of the early and mid-term follow-up periods of aortic valve replacement using the "TiAra" prosthesis. This study does not presuppose implementation of comparison groups.

Detailed description

Cardiovascular system diseases are one of the main causes of death worldwide. Heart valve diseases are considered one of the most important issues associated with the cardiovascular system. The replacement of heart valves includes the production of prostheses that provide functional consistency with exceptionally high reliability and appropriate fatigue strength. The proposed new biological valve with a frame made of super-elastic material allows preserves the natural biomechanics of the reconstructed valve and has high biocompatibility and resistance to infection due to the use of biological material as a frame covering. The "TiAra" bioprosthetic valve has the ability to deform during the cardiac cycle in accordance with the deformations of the fibrous structures of the patients' aortic root. The implanted valve fully integrates into the native aortic root. The purpose of these clinical trials is to obtain clinical data confirming the efficacy and safety of the bioprosthesis under normal conditions in humans. The expected clinical benefit involves the treatment of valvular disease with restoration of intracardiac hemodynamics during implantation of the "TiAra" bioprosthetic valve, followed by remodeling of the heart chambers, which should lead to an improvement in heart function and quality of life of the patient. The expected risks are associated with taking anticoagulant therapy during the first three months after implantation, or as a result of prolonged anticoagulant therapy, in the presence of concomitant rhythm disturbances, and consist in the possibility of hemorrhagic or thromboembolic complications. In order to reduce the risks caused by anticoagulant therapy, it is planned to carry out measures aimed at restoring the sinus rhythm and ensuring proper control of the indicators of the blood coagulation system.

Conditions

• Aortic Valve Disease
• Artificial Heart Valves

Timeline

• Start date: 2021-06-01
• Primary completion: 2025-08-10
• Completion: 2026-08-10
• First posted: 2023-08-21
• Last updated: 2024-09-25

Locations

1 site across 1 country: Russia